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Trial record 88 of 507 for:    ASPIRIN AND P2

Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT02514642
Recruitment Status : Unknown
Verified July 2015 by First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Recruiting
First Posted : August 4, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Brief Summary:
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy (DAPT) have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment elevation. However, few East Asian patients (or those of East Asian descent) have been included in these trials to assess the use of these drugs. In Korea and Japan, it has been reported that low doses of ticagrelor might have a more potent inhibition of platelet aggregation (IPA) than clopidogrel (75 mg once daily) in healthy subjects and patients with stable coronary artery disease, respectively. But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in a large population of Chinese ACS patients. A recent study on pharmacokinetics and tolerability of ticagrelor has found that maximum plasma concentration and area under the plasma concentration-time curve of ticagrelor (90 mg twice daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher in healthy Chinese volunteers compared with Caucasian subjects. This data also suggested that a low dose of ticagrelor might be more appropriate for Chinese ACS patients. In view of a large diurnal variation with a single daily dose, a lower dose twice daily may be a better choice for Chinese patients. Therefore, the investigators performed this randomized, single-blind, crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor (22.5 mg twice daily) in comparison to clopidogrel (75mg once daily) in Chinese patients with stable coronary artery disease.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: low-dose ticagrelor Drug: Clopidogrel Phase 4

Detailed Description:
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy (DAPT) have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment elevation. However, few East Asian patients (or those of East Asian descent) have been included in these trials to assess the use of these drugs. In addition, a growing body of data supported that East Asian might have different adverse event profiles (thrombophilia and bleeding) and "therapeutic window" compared with white subjects. Furthermore, "East Asian paradox" phenomenon has been also described that East Asian patients have a higher prevalence of platelet reactivity during DAPT, but an ischaemic event rate following percutaneous coronary intervention (PCI) or ACS is similar or even lower than white patients. In Korea and Japan, it has been reported that low doses of ticagrelor might have a more potent inhibition of platelet aggregation (IPA) than clopidogrel (75 mg once daily) in healthy subjects and patients with stable coronary artery disease, respectively. But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in a large population of Chinese ACS patients. A recent study on pharmacokinetics and tolerability of ticagrelor has found that maximum plasma concentration and area under the plasma concentration-time curve of ticagrelor (90 mg twice daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher in healthy Chinese volunteers compared with Caucasian subjects. This data also suggested that a low dose of ticagrelor might be more appropriate for Chinese ACS patients. In view of a large diurnal variation with a single daily dose, a lower dose twice daily may be a better choice for Chinese patients. Therefore, the investigators performed this randomized, single-blind, crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor (22.5 mg twice daily) in comparison to clopidogrel (75mg once daily) in Chinese patients with stable coronary artery disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Trial
Study Start Date : July 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: low-dose ticagrelor
To observe the safety and efficacy of low-dose ticagrelor in Chinese patients withStable Coronary Artery Disease
Drug: low-dose ticagrelor
low-dose ticagrelor (22.5 mg twice daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of clopidogrel (75mg once daily)
Other Name: low-dose ticagrelor(22.5 mg twice daily)

Drug: Clopidogrel
clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of low-dose ticagrelor (22.5 mg twice daily)
Other Name: clopidogrel (75mg once daily)

Active Comparator: clopidogrel
To observe the different safety and efficacy between low-dose ticagrelor and conventional-dose clopidogrel.
Drug: low-dose ticagrelor
low-dose ticagrelor (22.5 mg twice daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of clopidogrel (75mg once daily)
Other Name: low-dose ticagrelor(22.5 mg twice daily)

Drug: Clopidogrel
clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of low-dose ticagrelor (22.5 mg twice daily)
Other Name: clopidogrel (75mg once daily)




Primary Outcome Measures :
  1. P2Y12 reaction units (PRU) [ Time Frame: up to 5 months ]

Secondary Outcome Measures :
  1. inhibition of platelet aggregation (IPA) [ Time Frame: up to 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable Coronary Artery Disease

    1. stable angina
    2. low-risk unstable angina
    3. variant angina
    4. patients with asymptomatic with appropriate therapy(including percutaneous coronary intervention).

Exclusion Criteria:

  1. ACS
  2. planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists, or anticoagulant therapy during the study period
  3. platelet count <100g/L
  4. creatinine clearance rate < 30ml/min
  5. diagnosed as respiratory or circulatory instability (cardiac shock, severe congestive heart failure NYHA II-IV or left ventricular ejection fraction < 40%)
  6. a history of bleeding tendency
  7. aspirin, ticagrelor or clopidogrel allergies
  8. diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514642


Contacts
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Contact: Meijiao He, MM 86-451 -85555673 hemeijiao99@sina.com

Locations
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United States, California
VerifyNow Recruiting
San Diego, California, United States, 92101-92117
Contact: Meijiao He, Master    518-393-2200    customerservice@accriva.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Investigators
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Principal Investigator: Yue Li, MD Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University

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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT02514642     History of Changes
Other Study ID Numbers: SCAD-201523
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs